Brimonidine and timolol eye drops recalled over sterility assurance failure
Apotex is recalling two lots of Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution for lack of assurance of sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: this is an FDA Class II recall of a sterile ophthalmic product whose sterility cannot be assured, with no injuries stated.
Plain-English summary
Apotex Corp. is recalling Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%, 5 mL, sterile, prescription only, NDC 60505-0589-1. About 107,136 vials were distributed nationwide in the United States. The FDA has classified this recall as Class II.
The recall was initiated for lack of assurance of sterility.
Affected product covers lot VJ8599 (expiry 09/30/2026) and lot VL1668 (expiry 01/31/2027).
Patients and pharmacies can identify affected product by the NDC, lot numbers and expiry dates above, and may contact Apotex Corp. for further information.
The recalled product
- Product
- BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION (BRIMONIDINE TARTRATE AND TIMOLOL MALEATE)
- Brand
- BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION
- Manufacturer
- Apotex Corp.
- Category
- Drug — Ophthalmic
- Affected units
- 107,136
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lots VJ8599
- Exp Date 09/30/2026 & VL1668
- Exp Date 01/31/2027
Distribution
Distributed nationwide across the United States.
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